Evaluation of the Aurora Xi New Nomogram Software 2.0: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of the Aurora Xi New Nomogram Software 2.0 (NCT06122935), a randomized na study. The primary outcome is Rate of Significant Hypotensive Adverse Events.

2. Clinical Question

3. Trial Design

The registry describes a randomized, triple-masked, parallel-group trial. The two arms were the Test Group, using Aurora Xi New Nomogram Software 2.0, and the Control Group, using the marketed Aurora Xi Plasmapheresis System software version 1.3. Enrollment is listed as 6735. The record identifies the sponsor as Fenwal, Inc., lists the study status as completed, and gives a start date of 2023-11-27 and a primary completion date of 2024-04-19.

The clinical focus was significant hypotensive adverse events associated with plasma collection. The primary endpoint was specified as a count of procedures with a SHAE, with the timeframe extending from venipuncture through 72 hours post-donation. The stated objective was a relative-rate criterion: the rate with the new nomogram was to be less than double the comparator rate. The registry also lists secondary outcomes concerning severe hypotensive adverse events by donor characteristics, injury-related hypotensive events, and time to the first SHAE.

The arm summaries list 3363 in the Test Group and 3372 in the Control Group. They report 43 and 42 primary events, respectively. The registry record does not describe the sequence-generation method, how masking was implemented, the allocation concealment process, or whether randomization was stratified. Those design details are not reported in the registry record. A phase designation of NA is recorded.

The primary objective refers to the comparator as the Aurora Xi Optimized Nomogram algorithm, while the control-arm description identifies marketed software version 1.3. The record does not clarify the wording. This distinction should be kept in mind when describing the comparison rather than assuming an equivalence beyond the descriptions in the registry.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Rate of Significant Hypotensive Adverse Events, measured over From venipuncture through 72 hours post-donation..

The primary endpoint is the number of procedures with a significant hypotensive adverse event, abbreviated SHAE. The registry identifies the event classification as IQPP DAE 1.2–1.6 and specifies surveillance from venipuncture through 72 hours post-donation. This endpoint therefore concerns documented events within a defined post-donation window, rather than a measure of symptom severity averaged across all procedures.

The stated reason for comparing the groups is to assess whether the overall SHAE rate with the new nomogram is less than double the comparator rate. A relative-rate criterion frames the question around the event rate in one group in relation to the other; it is not the same as asking whether the event counts are identical. A valid rate comparison requires the event counts to be interpreted alongside the appropriate exposure denominators and the prespecified analysis method. The arm summaries list group sizes and event counts, but no primary rate estimate, confidence interval, or test result is reported in the registry record.

Hypotensive adverse events are clinically relevant to the trial’s stated safety focus, and the registry also lists related secondary outcomes. However, endpoint labels and counts alone do not describe event timing, severity beyond the stated classification, completeness of ascertainment, or how repeated events were handled. Those details are not reported in the registry record. The posted primary figures should therefore be read as descriptive counts, not as a complete inferential answer to the stated objective.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary endpoint count?

The registry defines the primary outcome as a procedure with a SHAE, classified as IQPP DAE 1.2–1.6. The timeframe is from venipuncture through 72 hours post-donation. The posted arm summaries report event counts alongside group sizes, but do not provide a calculated rate or a formal comparison. A count is a direct tally; a rate relates events to an amount of exposure or a population at risk. The denominator and the analysis method matter when interpreting a rate comparison, particularly if the exposure represented by each observation is not identical.

The primary objective uses a relative threshold: the new-nomogram rate is to be less than double the comparator rate. This is not an equality question. To evaluate such an objective, an analysis ordinarily needs an estimate of the relative rate and uncertainty around that estimate, interpreted using the prespecified decision criterion. The registry record does not report the primary estimate, uncertainty interval, or decision result. Those details are not reported in the registry record, so no conclusion about whether the criterion was met can be drawn from the event counts alone.

How should the secondary mean comparison be read?

The posted time-to-first-SHAE summaries use means and standard deviations. A mean gives the arithmetic average of observed times, while a standard deviation describes the spread of individual observations around that average. The unadjusted recalculation reports a mean difference of 3.73 minutes, with a 95% confidence interval from -8.797 to 16.26 and p = 0.559. The confidence interval represents a range of values compatible with the data under the calculation’s assumptions. Because it includes zero, the result does not distinguish clearly between a positive and a negative mean difference at conventional levels of statistical evidence.

A p-value describes how surprising a result at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions held. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. Here the p-value is unadjusted, and the registry record does not list a sponsor-reported analysis for this secondary outcome. The simple recalculation should therefore be regarded as exploratory rather than as a substitute for a reported trial analysis.

The standard deviations in the two groups are 10.22 and 40.2. Unequal spread can make a pooled-variance comparison less appropriate, and a small number of extreme times can influence means and standard deviations. The recalculation reports a pooled standard deviation of 29.02, but does not establish that the distributional assumptions are adequate. The registry record does not report distributions, medians, diagnostic checks, or a prespecified method for this endpoint. The observed summaries are therefore not enough to assess whether the normal-model approximation captures the data well.

Why does over-dispersion matter for event counts?

In general, count models often begin with assumptions about how much variation is expected in counts. Over-dispersion means the observed variation is greater than a basic model expects. If over-dispersion is present but ignored, standard errors may be too small and confidence intervals too narrow, making evidence appear more precise than it is. Other issues may also matter for rates, including repeated events, differing exposure time, and clustering by donor or procedure. The registry record does not state which model or variance assumptions were used for the primary outcome, or whether such checks were made.

What do planning illustrations mean?

Planning illustrations based on an observed effect are not observed power and do not describe how the trial was designed. The posted illustration uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect set at stated fractions of the observed effect. For example, planning for 75% of the observed effect gives 1,690 participants per arm for 80% power and 2,262 participants per arm for 90% power. These are hypothetical planning quantities, not trial findings. They depend on the observed effect being a suitable planning anchor and on the stated assumptions. The registry record does not report the trial’s own sample-size justification, target power, or design assumptions.

What is not established by these calculations?

The posted recalculation is unadjusted and based on summary statistics. It does not account for covariates, missing observations, multiplicity, or any model features not represented in those summaries. The record does not report whether the sponsor used a different analysis, whether any interim analyses were planned or conducted, or how analysis populations were defined. These details are not reported in the registry record. Without them, the calculations can clarify the arithmetic interpretation of posted summaries, but cannot reconstruct the complete statistical analysis plan or establish the primary trial conclusion.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple secondary outcomes, including outcomes stratified or examined by donor type, sex, age, and weight. It does not report whether statistical testing across these outcomes was adjusted for multiplicity, whether any outcomes were designated as confirmatory, or whether a testing hierarchy was prespecified. These details are not reported in the registry record. When many statistical questions are examined, unadjusted results have a greater chance of producing at least one apparently unusual finding by chance. This is why secondary p-values, if reported without a stated multiplicity approach, generally carry less weight than a prespecified primary analysis.

The posted results do not provide a clear account of missing data or the analysis populations. The primary arm summaries list group sizes and event counts, while the time-to-first-SHAE summaries include 44 observations in the Test Group and 42 in the Control Group. The registry does not explain how the secondary analysis set was formed, whether any observations were unavailable, or how missing values were handled. The record also does not specify whether analyses followed an intention-to-treat, per-protocol, or other population definition. These details are not reported in the registry record.

Without this information, it is difficult to assess whether exclusions or incomplete outcome recording could affect the comparison. For the primary endpoint, the record also does not report an analysis method, rate estimate, confidence interval, or test result. The presence of randomized groups does not itself establish how participants or procedures were included in each analysis. The registry does not report whether interim analyses were conducted or planned, or whether any adjustments were made for them. Those details are not reported in the registry record.

The time comparison is explicitly an unadjusted recalculation from posted summary statistics, and its p-value should be understood in that context. It is not evidence that multiplicity was handled, nor does it show that the trial’s own analysis used the same method. Overall, uncertainty about multiplicity, missingness, and analysis populations limits the strength of conclusions that can be drawn from the available secondary summaries.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry’s adverse-event figures list zero serious events for each group, with 26351 at risk in the Test Group and 26117 at risk in the Control Group. The same record lists 338 other adverse events in the Test Group and 309 in the Control Group, and zero deaths in both groups. These are registry safety counts, distinct from the primary endpoint summaries of procedures with a SHAE. The record does not explain how the safety denominators relate to the efficacy arm sizes or whether they represent procedures, event opportunities, or another unit.

A recorded count of zero serious events means that none were listed in the registry record for that group; it does not establish that the underlying risk is zero. Interpretation depends on the population monitored, the duration and completeness of follow-up, event definitions, and the process used to collect and classify events. Those details are not fully described in the record. The other adverse-event counts also should not be compared as rates without clarity about the denominators and analysis method.

The listed adverse-event figures do not by themselves establish a causal difference between software versions. They are descriptive safety information, and the registry does not report a formal comparative analysis of these figures.

12. What the Result Does, and Does Not, Mean

The posted data establish that the registry records 43 primary SHAE events in the Test Group and 42 in the Control Group, with respective group sizes of 3363 and 3372. They also establish the reported summaries for the time-to-first-SHAE secondary outcome and the adverse-event counts. These are descriptions of what is recorded, not a complete statistical evaluation of the primary objective.

The primary objective is framed as determining whether the rate with the new nomogram is less than double the comparator rate. The registry record does not report the primary rate comparison, its uncertainty, or a formal conclusion against that criterion. Therefore, the posted counts cannot establish that the objective was met, nor can they establish that it was not met. Similar-looking event counts do not demonstrate equivalence or noninferiority. Those conclusions require a suitable analysis and a decision rule that are not reported in the registry record.

The secondary time comparison is an unadjusted recalculation from the reported summaries. Its confidence interval includes zero, and its p-value is 0.559. This is not clear evidence of a difference in mean time, but it also does not prove that the means are equal. The uncertainty interval allows a range of possible differences, and the analysis uses fewer observations than the primary summaries. The registry does not explain the smaller secondary analysis set or report a sponsor analysis for this outcome.

Likewise, the safety figures describe recorded events but do not show that a software version caused, prevented, or changed the likelihood of an event. The registry does not give enough information about safety denominators, exposure, or comparative analyses to support that interpretation. A zero count is not evidence that an event is impossible, and a count difference is not automatically a rate difference.

In short, the record supports a limited descriptive reading, not a definitive claim about comparative safety or effectiveness. The primary inferential result, analysis populations, missing-data handling, and multiplicity approach are not reported in the registry record. Those gaps matter when moving from counts and exploratory summaries to a conclusion about the study’s stated objective.

13. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between a posted event count and the rate-based question that the study set out to address. The primary objective is not simply to compare whether the two groups had the same number of events. It asks whether the rate in the new-nomogram group is below a relative threshold compared with the comparator. That question requires a clearly defined denominator and an inferential analysis that quantifies uncertainty.

The primary summaries show 43 and 42 events in groups of 3363 and 3372. Those figures are informative descriptively, but counts alone do not reveal the uncertainty around the relative rate or whether the stated criterion was satisfied. This illustrates why a trial report should include the effect estimate, uncertainty interval, analysis method, and decision rule alongside arm-level counts. In their absence, readers may be tempted to overinterpret numerical similarity or to treat the event totals as a formal result.

The secondary time comparison provides another statistical teaching point. A mean difference and confidence interval communicate both direction and precision, while a p-value alone does not. Here the reported interval spans zero and the unadjusted p-value is 0.559, but the group standard deviations differ, and the analysis set is smaller than the primary arm summaries. This calls attention to distributional assumptions, the choice of summary statistic, and transparency about analysis populations.

Finally, the registry lists several secondary outcomes but does not describe a multiplicity strategy or provide most of their analyses. When numerous outcomes are considered, isolated unadjusted findings deserve caution. The record’s missing inferential details prevent a fuller evaluation of the primary claim and the consistency of secondary evidence. These limitations make transparent reporting—not a single event count—the central statistical issue.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most important trial-specific limitation in the registry record is the absence of an inferential result for the primary endpoint. Although the record lists group sizes and event counts, it does not report a primary rate estimate, confidence interval, p-value, or conclusion against the stated “less than double” objective. This prevents direct assessment of whether the primary criterion was met.

The primary objective refers to the Aurora Xi Optimized Nomogram algorithm, whereas the control-arm description names the marketed software version 1.3. The record does not clarify how these descriptions relate. The endpoint is described as procedures with a SHAE, but the record does not explain how repeat events or differences in exposure were handled in the analysis. The exact denominator used for the primary rate comparison is not reported.

For the secondary time outcome, the analysis includes 44 observations in the Test Group and 42 in the Control Group, while the primary arm summaries list 3363 and 3372. The registry does not explain the difference in analysis size, define the analysis population, or describe missing-data handling. The reported standard deviations differ substantially, and no distributional diagnostics or alternative summaries are reported. The unadjusted recalculation cannot address these uncertainties.

The registry also does not report a multiplicity approach for its several secondary outcomes, a detailed statistical analysis plan, or whether interim analyses occurred. Safety counts are reported with denominators that are not reconciled with the primary arm sizes, and no comparative safety analysis is given. These gaps are specific to interpreting this record; they do not establish that the underlying trial lacked such procedures or analyses, only that they are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of the Aurora Xi New Nomogram Software 2.0 — NCT06122935.
• Registry record last updated 2025-11-12; status last verified 2025-10.
• Results first posted 2025-11-12.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT06122935 is a completed randomized, triple-masked, parallel-group trial sponsored by Fenwal, Inc. It compared Aurora Xi New Nomogram Software 2.0 with marketed Aurora Xi software version 1.3 for plasma collection. The registry lists enrollment as 6735 and focuses on significant hypotensive adverse events.

The primary objective was to assess whether the SHAE rate with the new nomogram was less than double the comparator rate. The posted primary summaries list 43 events in the Test Group and 42 in the Control Group, but the primary inferential comparison is not reported in the registry record. A secondary time-to-first-SHAE summary includes an unadjusted recalculation, while most listed secondary outcomes have no reported analyses. The record also lists adverse-event counts, but does not provide enough detail to interpret them as comparative rates.